Quick Facts at a Glance
- Recall Date
- January 12, 2026
- Hazard Level
- HIGH
- Brand
- Waldemar Link
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Waldemar Link
- Product type
- Orthopedic implant component
- Model numbers
- Item Number: 15-2836/11, UDI-DI: 04026575316571, Serial/Lot Number: 250623/3643, Serial/Lot Number: 250623/3644, Serial/Lot Number: 250623/3645, Serial/Lot Number: 250623/3646, Serial/Lot Number: 250623/3648, Serial/Lot Number: 250812/2812 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 12, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter
About This Product
Endo-Model Replacement Plateau is an orthopedic implant component used in surgical fixation. It is intended to provide stability in the implanted construct when used by trained surgeons.
Why This Is Dangerous
If the bushing detaches from the screw shaft due to a longitudinal fracture, the implant may lose integrity, possibly requiring surgical intervention.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Patients could require additional surgery. Healthcare providers must assess device stability and determine whether replacement or repair is necessary.
Practical Guidance
How to identify if yours is affected
- Verify Item Number 15-2836/11
- Cross-check with FDA recall Z-1516-2026 page
Where to find product info
Recall letter from Waldemar Link. FDA recall page Z-1516-2026.
What timeline to expect
Refund or replacement timelines are determined by the manufacturer; typical timelines can vary widely in medical device recalls.
If the manufacturer is unresponsive
- Consult your surgeon or healthcare provider.
- File a formal report with the manufacturer and consult FDA guidelines if needed.
How to prevent similar issues
- Verify device identifiers before implantation.
- Maintain a clear line of communication with the surgical team and device supplier.
- Request documented recalls and replacements in writing.
Documentation advice
Keep the recall notice, device identifiers, medical records, and all correspondence with the manufacturer.
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Product Details
Model numbers and identifiers include Item Number 15-2836/11 and UDI-DI 04026575316571. Serial/Lot Numbers affected include 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, and 250812/2811. Recall date: 2026-01-12. Distribution: Worldwide, including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Quantity: 7 units (OUS only). Manufacturer: Waldemar Link GmbH & Co. KG. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 7 units recalled worldwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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